🇦🇺 Macitentan and Tadalafil in Australia

Macitentan and Tadalafil (Macitentan and Tadalafil) regulatory status in Australia.

Marketing authorisation

TGA

  • Status: likely_approved

Macitentan and Tadalafil in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Macitentan and Tadalafil approved in Australia?

Yes. TGA has authorised it.

Who is the marketing authorisation holder for Macitentan and Tadalafil in Australia?

Humanis Saglık Anonim Sirketi is the originator. The local marketing authorisation holder may differ — check the official source linked above.